A Phase 1 Study of Mixed Bacteria Vaccine (MBV) in Patients With Tumors Expressing NY-ESO-1 Antigen

Inclusion Criteria:

• Histologically confirmed metastatic melanoma, head and neck cancer, transitional cell carcinoma, sarcoma, GIST (gastrointestinal stroma tumor) or prostate cancer
• Tumor expression of 1) NY-ESO-1 by reverse transcriptase and polymerase chain reaction (RT-PCR) analysis (see Appendix 1), preferably, or immunohistochemistry (20);
• Expected survival of at least 6 months.
• Karnofsky performance scale >/-70 %.
• Fully recovered from surgery.

• Declined, intolerated or completed standard therapy defined as following for each tumor entity:

  • Melanoma- Resistance or intolerance to Dacarbazine.
  • Sarcoma-Resistance or intolerance to Anthracyclines and to one Platinum containing chemotherapy regimen, no indication for irradiation.
  • GIST (gastrointestinal stroma tumor)- Failure or intolerance of Imatinib and Sunitinib
  • Head and Neck Cancer -No indication for irradiation, resistance or intolerance to platinum containing chemotherapy.
  • Transitional Cell Carcinoma - Resistance or intolerance to Cisplatin combined with Gemcitabine
  • Prostate Cancer- Failure of antihormonal treatment and resistance or intolerance to Docetaxel

• Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified:

  • Absolute neutrophil count (ANC) >/- 1,000/mm3
  • Platelets >/-75,000/mm3
  • Creatinine </- 2 mg/dL
  • ALT, AST </- 5 x ULN
  • Alk Phos and total bilirubin </- 2.5 x ULN
• Age ≥ 18 years
• Able and willing to give valid written informed consent

Exclusion Criteria:

• Clinically significant heart disease (NYHA Class III or IV).
• Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders.
• Patients with serious intercurrent illness, requiring hospitalization.
• Known HIV positivity
• Chemotherapy, radiation therapy or immunotherapy within 4 weeks prior to first dose of study agent (6 weeks for nitrosoureas).
• Known autoimmune disease (RA, SLE), as these conditions might interfere with the evaluation of the induced immune response. Patients with vitiligo or melanoma-associated hypopigmentation are not excluded.
• Chronic use of immunosuppressive drugs such as systemic corticosteroids.
• Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
• Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
• Lack of availability for immunological and clinical follow-up assessments.
• Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dosing of study agent.
• Pregnancy or breastfeeding.
• Women of childbearing potential: Refusal or inability to use effective means of contraception.